TAG:
clinical laboratory test
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…
HHS ‘Stands Down’ FDA on Its Oversight of LDTs
CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…
Quest Reports 46% Decline in New Cancer Diagnoses in March
ONCE SHELTER-IN-PLACE ORDERS WERE ENACTED IN MARCH because of the COVID-19 pandemic, the number of new diagnoses of cancer declined sharply in the United States. Newly-published data confirms this fact. The data also support the warnings of anatomic pathologists that—because of the pandemi…
Wisconsin Lab Network Feeds Valuable Data to State Health Lab
CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and ca…
August 24, 2020 Intelligence: Late-Breaking Lab News
Currently at least 15 veterinary laboratories in the United States perform COVID-19 tests. This fact was confirmed by Adm. Brett Giroir, MD, the Assistant Secretary of the Department of Health and Human Services (HHS), during an interview last month conducted by CNN. Officials at HHS confi…
Amazon Targets COVID-19 Testing in its New Lab-Building Venture
This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 t…
UHC Ready to Implement New Lab Test Registry
CEO SUMMARY: UnitedHealthcare announced that its new Test-Registry Protocol will become effective on Jan. 1, 2021, creating a major billing hurdle for labs and pathology groups. By that date, a lab must register each type of test before it can submit claims for these tests to the nati…
UHC Issues Details about How Labs Register Tests
CEO SUMMARY: As of January 1, UnitedHealthcare will require all clinical laboratories and anatomic pathology groups to register every type of test before labs can bill for those tests. Not only is the COVID-19 pandemic disrupting normal activity, but the administrative burden UHC is i…
Amazon Building Labs to Do COVID-19 Testing
CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent lab-testing venture for employees could be a significant concern given that the e-commerce company could disrupt the clinical lab business nationwide. The online retail giant has long had an interest in medic…
Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?
This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnos…
CURRENT ISSUE
Volume XXVII, No. 12 – August 24, 2020
THE DARK REPORT lines up its top lab industry experts to analyze a surprising development: The department of Health and Human Services’ welcome announcement that the Food and Drug Administration does not need to issue an Emergency Use Authorization for laboratory-developed tests. This announcement is significant because EUAs for LDTs have been a long-running irritant to labs. But lab managers will want to consider whether liability issues make a voluntary EUA advisable, based on TDR’s analysis.
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